Clinical Trials Logo
  1. Home
  2. Non-Small Cell Lung Cancer
  3. NCT00369447

A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer

Non-small-cell Lung Cancer Clinical Trial

Official title:
A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC

Clinical Trial Summary

This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment.

The Phase I component of this study has been completed. The Phase II is now closed to recruitment.

Clinical Trial Description

This is a randomized, double blind, multicenter Phase II study with Phase I lead-in. Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy (curative intent chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II component of the study. In the Phase II component, overall survival, local and systemic response rates and quality of life will be evaluated inpatients treated with nimotuzumab in combination with palliative radiation vs. radiation alone.

The Phase I component of this study has been completed. The Phase II is now closed to recruitment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00369447
Study type Interventional
Source YM BioSciences
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date March 2009
Completion date July 2011
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02495233 - A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) Phase 1/Phase 2
Withdrawn NCT02672358 - Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC Phase 2
Recruiting NCT05815472 - Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) N/A
Not yet recruiting NCT05900219 - Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study Phase 2
Not yet recruiting NCT04560244 - A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment Phase 2
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT01924416 - Lung Cancer Information Study (LCIS-R01) N/A
Completed NCT01136083 - Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients N/A
Completed NCT00831454 - Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection N/A
Completed NCT00363766 - Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Completed NCT00913705 - Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer Phase 3
Completed NCT01383135 - Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2 Early Phase 1
Completed NCT01124864 - A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy. Phase 2
Completed NCT00049998 - Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer Phase 3
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT03320044 - Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Recruiting NCT04895930 - Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC Phase 2
Recruiting NCT03267654 - Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2
Recruiting NCT04401059 - Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study Phase 4
Not yet recruiting NCT02930954 - Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2